A Mono-centric, First In-human (FIH), Safety and Preliminary Efficacy Study of (Neo)Adjuvant, Model-based, Whole-body Hyperthermia (WBHT) Treatment in Advanced Solid Cancer Patients or Stage IV (TxNxM1) Metastatic Pancreatic Adenocarcinoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ElmediX
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) related to WBHT treatment alone or in combination with SOC chemotherapy according to the NCCN guidelines. nab-paclitaxel or gemcitabine alone
研究概览
简要总结
Millions of patients die of cancer every year. There are several methods to treat cancer, including surgery, chemotherapy, radiotherapy and immunotherapy. Recently, hyperthermia therapy started playing a role in cancer therapy. It has shown effect in animal experiments and clinical practice. The sponsor has developed a novel device to use hyperthermia for advanced cancer. This study is to prove the safety in human patients of this device & therapy and get the first data on efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A1
Three patients with advanced solid cancer will be subjected to repetitive hyperthermia starting with 2 hours (day 1), 4 hours (day 8) and 6 hours (day 15)
干预措施: Whole body hyperthermia (Device)
Cohort A2
One patient with advanced solid cancer will receive 3 hyperthermia treatments of 4 hours per treatment. The next patient with advanced solid cancer will receive 3 hyperthermia treatments of 6 hours per treatment.
干预措施: Whole body hyperthermia (Device)
Cohort B
Three pancreatic cancer patients will be subjected to three hyperthermia treatments (2 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
干预措施: Whole body hyperthermia (Device)
Cohort B
Three pancreatic cancer patients will be subjected to three hyperthermia treatments (2 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
干预措施: Standard of Care (SOC) chemotherapy according to the NCCN guidelines. (Drug)
Cohort C
Three pancreatic cancer patients will be subjected to three hyperthermia treatments (4 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
干预措施: Whole body hyperthermia (Device)
Cohort C
Three pancreatic cancer patients will be subjected to three hyperthermia treatments (4 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
干预措施: Standard of Care (SOC) chemotherapy according to the NCCN guidelines. (Drug)
Cohort D
Three pancreatic cancer patients will be subjected to three hyperthermia treatments (6 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
干预措施: Whole body hyperthermia (Device)
Cohort D
Three pancreatic cancer patients will be subjected to three hyperthermia treatments (6 hours duration per treatment) alone (1st treatment) or in combination with (2nd and 3rd treatment) Standard of Care (SOC) chemotherapy according to the NCCN guidelines.
干预措施: Standard of Care (SOC) chemotherapy according to the NCCN guidelines. (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) related to WBHT treatment alone or in combination with SOC chemotherapy according to the NCCN guidelines. nab-paclitaxel or gemcitabine alone
时间窗: 4 weeks after last treatment
Incidence of adverse device events (ADEs) in relation to the medical device
时间窗: 4 weeks after last treatment
Incidence of related clinically significant abnormalities on electrocardiogram (ECG), vital signs, physical examination and laboratory parameters
时间窗: 4 weeks after last treatment
次要结局
- evolution of CEA (ng/ml)(4 weeks after last treatment)
- based on the three primary outcome measures, guidance will be drafted for phase II treatment duration in combination with chemotherapy dosing.(4 weeks after last treatment)
- evolution of CA19-9 (U/ml)(4 weeks after last treatment)